Transcript 10-CMSMDS-1 training slides

10-CMSMDS-1 Study
Training Slides
SUM07_1.ppt
Overview
Primary Study Objectives
 To prospectively examine outcomes of
allogeneic HCT in adults > 65 years of age
with MDS to determine whether their
outcomes are similar to those in younger
patients
 To provide a mechanism for coverage for
patients with MDS who are Medicare
beneficiaries under a CED (Coverage with
Evidence Decision)
Overview of Study Requirements
Complete and submit the Center Verification of Participation
form
Maintain IRB approval of Research Database Protocol and
Consent
Consent eligible patients using the Research Database
consent form
Submit paper registration form for each patient to be
enrolled.
Study participants will be assigned to the CRF track
Completion of Form 2400 ( Pre-TED)
Center Verification
 Return to CIBMTR-Mpls, the Center
Verification form to confirm that your center
is or is not participating in CMS-MDS study.
 For participating centers, all patients
registered to this study will be assigned to
the CRF track.
This form can be either faxed or emailed to:
Anne Dircks
612-884-8660 (Fax)
[email protected]
IRB Approval
Is IRB approval required for the CMS-MDS
study plan?
 It is required that each participating center
maintain IRB approval of the Research
Database Protocol and Consent
 Submission of the 10-CMSMDS-1 study plan
to your local IRB is not required but may be
submitted if needed.
How to Consent Patients
 All patients will be consented using the IRB
approved Research Database study consent.
There is not a separate consent form that is
specific for the 10-CMSMDS-1.
 Agreement to participate in the Research
Database study also allows for eligible patients
to enroll onto the 10-CMSMDS-1 study.
Registration Form
 For all eligible patients who have signed consent,
submission of the CMS-MDS paper registration
form is required. The form can be found on the
CIBMTR study page, and contains submission
instructions.
 The purpose of this form is to track study
enrollment to ensure that all eligible patients are
appropriately registered to the study.
Form 2400 (Pre-TED) Completion
To properly enroll a study patient, the following
two fields on the Pre-TED form are required to
be completed:
 Under Recipient Identification-The RCI-BMT
box must be checked, and the
St ID# 10-CMSMDS-1 must entered in the
specify field.
 Consented to Research question should also
be marked as Yes.
This will ensure that the patient is properly
enrolled on to the CMS-MDS study and
assigned to the CRF track.
Form 2400 Screen Shot Example
RECIPIENT IDENTIFICATION
CIBMTR recipient ID#:
______________________________________
ID assigned by: 􀂉CIBMTR 􀂉EBMT 􀂉Other
__________________
􀂉BMT-CTN, St ID #:_______ 􀂉RCI-BMT, St ID #:_______ 􀂉
NMDP 􀂉SCTOD
Consented for Research? 􀂉 Yes 􀂉 No
Consented for CIBMTR Related Specimen Repository? 􀂉Yes 􀂉
No
Gender: 􀂉Male 􀂉Female DOB:___ ___ ___ ___ - ___ ___ - ___
___
YYYYM M
CMS coverage
 For information regarding Medicare
claim policies and instructions, please
go to the study webpage
www.cibmtr.org/HCTforMDS and look
under “Guidance for Providers”
Study Related Materials
All study related materials can be found
on the study web page at:
www.cibmtr.org/HCTforMDS
Questions
 For any study related questions, please
contact
Anne Dircks
Sr. Clinical Research Specialist
612.884.8209
[email protected]